GEMS (Gepant Efficacy in Ménière's Study)
The Gepant Efficacy in Ménière’s Study (GEMS) is a research study investigating whether ubrogepant (Ubrelvy) may help shorten episodes of vertigo in people with Ménière’s disease. Ubrogepant is an FDA-approved medication currently used to treat migraine, but it has not been approved to treat Ménière’s disease. Researchers are studying whether blocking a pathway involved in migraine may also help reduce the duration and severity of Ménière’s disease attacks.
Participants in the study will receive both ubrogepant and placebo tablets to take during separate Ménière’s attacks. Neither the participant nor the study team will know which type of tablet is taken during an individual attack. Researchers will compare participants’ symptoms after each treatment to learn whether ubrogepant reduces the duration of vertigo and improves other symptoms associated with Ménière’s attacks.
The study lasts approximately 4 months and includes:
- 3 in person study visits
- 2 hearing evaluations
- Daily symptom surveys, and surveys completed during Ménière’s attacks.
Some participants may also have the option to contribute information using devices such as an Apple Watch, AirPods, or an iPhone-based eye-movement assessment.
Who may be eligible?
You may be eligible if you:
- Are 18–75 years old
- Have a diagnosis of definite Ménière’s disease
- Have access to a Iphone smartphone
- Are able to complete study surveys in English
- Experience recurring Ménière’s attacks
Additional eligibility requirements will be reviewed by the study team. During the first 28 days of the study, participants must record at least two qualifying Ménière’s attacks before moving into the treatment portion of the study.
What does participation involve?
The study begins with a 28-day observation period during which participants track their symptoms and Ménière’s attacks. Participants who continue to qualify will then receive a study medication pack containing both ubrogepant and placebo tablets. During eligible Ménière’s attacks, participants will take the next numbered study tablet and report their symptoms through the study’s electronic survey system.
Participants may receive up to $100 in electronic gift cards for completing study visits.
Interested in participating?
If you have Ménière’s disease and would like to learn more about the GEMS Study, please complete the study interest form below. A member of the research team will contact you to discuss the study and determine whether you may be eligible.
Additional questions can be directed towards research coordinator Grant Stille [email protected] and Jasmine Trombley [email protected].
Protocol of this study can be accessed HERE.